CompletedPhase 3

Immunogenicity and Safety Study of Self-amplifying mRNA COVID-19 Vaccine Administered With Influenza Vaccines in Adults

Australia1,514 participantsStarted 2024-03-27

Plain-language summary

This is a multicenter, observer-blind, randomized, controlled phase 3 study to evaluate the immunogenicity, reactogenicity, and safety of an investigational self-amplifying RNA COVID-19 vaccine (ARCT-2303) administered concomitantly with quadrivalent influenza vaccines or standalone in adults who previously received authorized COVID-19 vaccine.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Individuals with acute medical illness or febrile illness.
✕. Individuals with a positive SARS-CoV-2 rapid antigen test at Screening.
✕. Individuals with a history of COVID-19 or virologically confirmed SARS-CoV-2 infection within the past 5 months or history of COVID-19 with ongoing sequelae.
✕. Individuals with a known history of severe hypersensitivity reactions, including anaphylaxis, or other significant adverse reactions to any components of mRNA vaccine, or influenza vaccine, including egg protein.
✕. Individuals who have a positive pregnancy test at the Screening visit or who intend to become pregnant or breastfeed during the study.
✕. Individuals with a history of myocarditis, pericarditis, myopericarditis or cardiomyopathy.
✕. Individuals with a history of Guillain-Barré syndrome, encephalomyelitis, or transverse myelitis.
✕. Individuals with a history of congenital or acquired immunodeficiency.

What they're measuring

Groups 2a and 2b and ARCT-154-J01 Historical Control: Geometric Mean Titers (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody Titers Against Omicron XBB.1.5 Subvariant at Day 29

Timeframe: Day 29

Groups 2a and 2b and ARCT-154-J01 Historical Control: Number of Participants With Seroconversion to SARS-CoV-2 Neutralizing Antibody Against Omicron XBB.1.5 Subvariant at Day 29

Timeframe: Day 29

Groups 1a and 3a: Adjusted Hemagglutination Inhibition (HI) GMTs Against Influenza Vaccine Strains at Day 29

Timeframe: Day 29

Groups 1a and 2a: Adjusted GMTs of SARS-CoV-2 Neutralizing Antibody Against Omicron XBB.1.5 Subvariant at Day 29

Timeframe: Day 29

Trial details

NCT IDNCT06279871

SponsorArcturus Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-09

Results submitted2025-10-07

View on ClinicalTrials.gov More COVID-19 trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Individuals with acute medical illness or febrile illness.
✕. Individuals with a positive SARS-CoV-2 rapid antigen test at Screening.
✕. Individuals with a history of COVID-19 or virologically confirmed SARS-CoV-2 infection within the past 5 months or history of COVID-19 with ongoing sequelae.
✕. Individuals with a known history of severe hypersensitivity reactions, including anaphylaxis, or other significant adverse reactions to any components of mRNA vaccine, or influenza vaccine, including egg protein.
✕. Individuals who have a positive pregnancy test at the Screening visit or who intend to become pregnant or breastfeed during the study.
✕. Individuals with a history of myocarditis, pericarditis, myopericarditis or cardiomyopathy.
✕. Individuals with a history of Guillain-Barré syndrome, encephalomyelitis, or transverse myelitis.
✕. Individuals with a history of congenital or acquired immunodeficiency.

What they're measuring

Timeframe: Day 29

Groups 2a and 2b and ARCT-154-J01 Historical Control: Number of Participants With Seroconversion to SARS-CoV-2 Neutralizing Antibody Against Omicron XBB.1.5 Subvariant at Day 29

Timeframe: Day 29

Groups 1a and 3a: Adjusted Hemagglutination Inhibition (HI) GMTs Against Influenza Vaccine Strains at Day 29

Timeframe: Day 29

Groups 1a and 2a: Adjusted GMTs of SARS-CoV-2 Neutralizing Antibody Against Omicron XBB.1.5 Subvariant at Day 29

Timeframe: Day 29